Recall archive / FDA device enforcement
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 — FDA record Z-1270-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
- Reason
- Due to a potential failed sterilization process.
- Classification
- Class II
- Recalling firm
- Volcano Corp
- Quantity
- 11 devices
- Agency-reported status
- Terminated
- Source record identifier
- Z-1270-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: 89185J Part Number: 300000252891 UDI Code: (01)00845225003050(11)220309(17)250309(10)0302535768 Serial Numbers: 37583 37586 37590 37598 37612 37648 37655 37692 37694 37709 37719 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: WA and WI O.U.S.: Canada
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 22, 2022
- Recall initiation date
- May 16, 2022
- Center classification date
- Jun 16, 2022
- Termination date
- Dec 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.